Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients (IFaB)

This study has been withdrawn prior to enrollment.
(Recruitment problems)
Sponsor:
Information provided by (Responsible Party):
Holger Cramer, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT01686737
First received: September 12, 2012
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

Breast cancer is the most frequent cancer in women and is associated with profound restrictions of health-related quality of life and psychosocial health. More than three-quarters of women with breast cancer suffer from fatigue during cancer treatment. While exercise interventions can improve fatigue in breast cancer patients, many patients request complementary treatment approaches. Therefore, this study investigates the effects of yoga in women with breast cancer compared to aerobic exercise and usual care.

It is hypothesized that yoga is more effective than usual care and equally effective as aerobic exercise.


Condition Intervention
Breast Neoplasms
Fatigue
Behavioral: Iyengar Yoga
Behavioral: Walking

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Universität Duisburg-Essen:

Primary Outcome Measures:
  • Fatigue [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Multidimensional Fatigue Inventory


Secondary Outcome Measures:
  • Fatigue [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    Multidimensional Fatigue Inventory

  • Health-related quality of life [ Time Frame: Week 12, week 36 ] [ Designated as safety issue: No ]
    Functional Assessment of Cancer Therapy - Breast

  • Depression and anxiety [ Time Frame: Week 12, week 36 ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale

  • Sleep quality [ Time Frame: Week 12, week 36 ] [ Designated as safety issue: No ]
    Pittsburgh Sleep Quality Index

  • Perceived Stress [ Time Frame: Week 12, week 36 ] [ Designated as safety issue: No ]
    • Perceived Stress Scale
    • Impact of Event Scale

  • Salivary Cortisol [ Time Frame: Week 12, week 36 ] [ Designated as safety issue: No ]
    Cortisol awakening response

  • Safety [ Time Frame: Week 0-36 ] [ Designated as safety issue: Yes ]
    Adverse events


Enrollment: 0
Study Start Date: November 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Yoga

Iyengar Yoga

  • 12 weeks of Iyengar yoga
  • 2 weekly sessions of 60 minutes
Behavioral: Iyengar Yoga
  • 12 weeks of Iyengar yoga
  • 2 weekly sessions of 60 minutes
Active Comparator: Aerobic exercise

Walking

  • 12 weeks of walking
  • 2 weekly sessions of 60 minutes
Behavioral: Walking
  • 12 weeks of walking
  • 2 weekly sessions of 60 minutes
No Intervention: Usual Care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • non-metastatic invasive breast cancer
  • currently receiving adjuvant chemotherapy
  • moderate to severe chemotherapy-induced fatigue
  • physical and cognitive capacity to participate in yoga or walking

Exclusion Criteria:

  • diagnosed and pharmacologically treated psychiatric disorder except depressive adaptation disorder as a reaction to cancer diagnosis
  • ECOG status > 1
  • prior malignancy with a disease-free survival < 10 years except curatively treated basalioma of the skin and carcinoma in situ of the cervix
  • prior ductal carcinoma in situ (DCIS) ot the breast
  • pregnancy or breastfeeding
  • regular practice of yoga or walking during the past 12 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01686737

Locations
Germany
Klinik für Senologie / Brustzentrum, Kliniken Essen-Mitte
Essen, Germany, 45136
Brustzentrum Köln-Hohenlind, St. Elisabeth-Krankenhaus Köln-Hohenlind
Köln, Germany, 50935
Sponsors and Collaborators
Universität Duisburg-Essen
Investigators
Principal Investigator: Holger Cramer, PhD University of Duisburg-Essen, Chair of Complementary and Integrative Medicine
Study Director: Gustav J. Dobos, MD University of Duisburg-Essen, Chair of Complementary and Integrative Medicine
  More Information

No publications provided

Responsible Party: Holger Cramer, Postdoctoral fellow, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT01686737     History of Changes
Other Study ID Numbers: 2012210
Study First Received: September 12, 2012
Last Updated: February 4, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014